Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones i… (NCT06628765) | Clinical Trial Compass
RecruitingNot Applicable
Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children
China52 participantsStarted 2024-10-08
Plain-language summary
The single-use digital flexible Ureteroscopy (fURS) is commonly used for the treatment of upper urinary tract stones. The size of the outer diameter of the fURS can affect the safety, efficacy, and medical costs of the treatment. Particularly for children, their ureters are thinner and more tortuous compared to adults, which places higher demands on medical devices. The investigators are interested in determining if the performance of the two different sizes of fURS (6.3 Fr vs. 8.6 Fr) are equivalent. This study will have guiding significance for the selection of upper urinary tract stones surgery in children in the future.
Who can participate
Age range
0 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients scheduled for ureteroscopy and laser lithotripsy for individual renal stones ranging in size from 5 mm to 20 mm in all intrarenal locations (If there are multiple stones present, the total stone burden in cross section should not exceed 20 mm)
* Patients \< 14 years
* For children younger than 8 years old, the informed consent form is signed by the parents; for children older than 8 years old, the informed consent form is signed by both the parents and the child themselves.
Exclusion Criteria:
* Children with uncontrolled urinary tract infections or coagulation disorders and other contraindications for surgery before the operation.
* Children with severe renal insufficiency, anatomical or functional solitary kidney, known nephrocalcinosis, and other significant comorbidities that are not suitable for participating in the study.
* Children who refuse to participate in this study.
* Any other reason that in the opinion of the investigator would make the participant unsuitable for enrollment in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The success rate of the first fURS insertion
Timeframe: During the procedure
Trial details
NCT IDNCT06628765
SponsorThe Children's Hospital of Zhejiang University School of Medicine